It is known in the prior art that there is a high incidence of gastrointestinal side effects associated with a number of known antibiotics including tetracycline antibiotics. These side effects include nausea and dyspepsia, particularly when taken on an empty stomach. Other side effects include reaction of the central nervous system leading to ataxia, lightheadedness, dizziness or vertigo. While it is known in the prior art to provide an enteric coating to reduce side effects by avoiding dissolution in the stomach, such enteric coatings may also prevent adequate absorption of the antibiotic. Accordingly, a product offering at least partial protection against these adverse reactions would have definite advantages over all the rest of the drug products in this group.
Accordingly, it is an object of the present invention to overcome, or at least alleviate, one or more of the difficulties related to the prior art.
Accordingly, in a first aspect according to the present invention there is provided
a pharmaceutical composition including
a core element including at least one active ingredient including at least one tetracycline antibiotic; and
a core coating for the core element which is partially soluble at an acidic pH and which, in use, generates a dissolution profile for the pellet composition which is equal to or greater than the minimum dissolution profile required to provide bioequivalence with a capsule or tablet containing an equal amount of the at least one active ingredient in an uncoated form.